Insulatard100 IU/ml

Insulatard is a biosynthetic (recombinant DNA-derived) human insulin formulated to provide a slow, prolonged (long-acting/basal) glucose-lowering effect. It is indicated for the treatment of diabetes mellitus as part of a regimen that provides background (basal) insulin coverage.

Established/FDA-recognized uses

• Type 1 diabetes mellitus — as the basal component of a basal-bolus insulin regimen, used together with a rapid- or short-acting insulin for mealtime coverage.
• Type 2 diabetes mellitus — for glycemic control when diet, exercise, and oral antidiabetic agents do not provide adequate control, either alone or combined with oral antidiabetic drugs.

Important limitation

Insulatard is not intended for the treatment of diabetic ketoacidosis or acute severe hyperglycemia; a rapid- or short-acting insulin given intravenously under medical supervision is required for those emergencies, because Insulatard has a slow onset and is given only by subcutaneous injection.

Each mL contains biosynthetic human insulin (produced by recombinant DNA technology) formulated as a long-acting suspension, typically at a strength of 100 IU/mL (U-100), for subcutaneous injection. Insulin Human [Long-Acting] contains zinc and other suspending/stabilizing excipients that slow its absorption from the injection site.

Insulatard is a sterile, long-acting suspension of purified human insulin manufactured using recombinant DNA technology, structurally identical to insulin produced by the human pancreas. Unlike rapid- or short-acting insulins, Insulatard is formulated (as an extended zinc-insulin suspension) to dissolve slowly after subcutaneous injection, giving it a delayed onset and a prolonged, relatively flat duration of action suited to providing steady background (basal) insulin levels rather than covering the rise in blood glucose after meals.

Insulatard belongs to the class of long-acting (basal) human insulins, a subclass of antidiabetic agents/insulins used for glycemic control in diabetes mellitus.

Like all insulins, Insulin Human [Long-Acting] lowers blood glucose by binding to insulin receptors on muscle, fat, and liver cells. This stimulates peripheral glucose uptake (particularly into skeletal muscle and adipose tissue), suppresses hepatic glucose production and release, and inhibits lipolysis and proteolysis, while promoting protein synthesis.

Basal vs. mealtime action

Insulin Human [Long-Acting] is distinguished from rapid- and short-acting insulins by its pharmacokinetic profile: after subcutaneous injection it forms a depot that dissolves slowly, giving a delayed onset of action (approximately 4-6 hours), a broad and relatively low peak effect (roughly 8-20 hours), and a prolonged duration of action (approximately 24-36 hours). This flatter, longer profile makes Insulin Human [Long-Acting] suitable for providing steady, background (basal) insulin coverage between meals and overnight, rather than for controlling the glucose rise that follows a meal, which requires a rapid- or short-acting insulin instead.

Insulatard is administered by subcutaneous injection only, with rotation of injection sites (abdomen, thigh, buttock, or upper arm). It must never be given intravenously or intramuscularly. See Dosage and Administration for full technique.

Many medicines can affect blood glucose control and change the insulin dose needed when taking Insulatard. Report all medicines to the prescribing physician.

• Other antidiabetic agents, ACE inhibitors, MAO inhibitors, and salicylates — may enhance the blood-glucose-lowering effect of Insulatard, increasing hypoglycemia risk.
• Corticosteroids, thiazide diuretics, thyroid hormones, and estrogen/progestogens — may raise blood glucose and reduce the effectiveness of Insulatard, sometimes requiring a dose increase.
• Beta-blockers — may blunt or mask the warning symptoms of hypoglycemia (such as tremor and palpitations), making low blood sugar harder to recognize.
• Alcohol — can unpredictably increase or prolong the hypoglycemic effect of Insulatard; intake should be limited and discussed with the physician.

The most common and most important adverse effect of Insulatard is hypoglycemia, which can range from mild (sweating, tremor, hunger, palpitations, confusion) to severe (seizures, loss of consciousness) and requires prompt treatment.

• Hypoglycemia — the most frequent risk; see Precautions and Warnings for prevention and management.
• Injection-site reactions — redness, swelling, itching, or pain at the injection site, usually mild and transient.
• Lipodystrophy — thickening or pitting of fat tissue at repeatedly used injection sites; prevented by site rotation.
• Weight gain and peripheral edema — can occur with improved glycemic control.
• Hypokalemia — insulin shifts potassium into cells and can lower serum potassium, which is of particular concern with concurrent potassium-lowering drugs or illness.
• Allergic reactions — rare; generalized rash, angioedema, or, very rarely, anaphylaxis.

Good glycemic control before conception and throughout pregnancy is important for both mother and baby, and insulin (including Insulatard) is a standard treatment option for diabetes during pregnancy. However, Insulatard should be used in pregnancy only under close physician supervision, as insulin requirements typically change during each trimester and around delivery, and doses must be adjusted based on frequent blood glucose monitoring. Use only if clearly needed and if the potential benefit justifies the potential risk; always consult a physician before starting or continuing Insulatard during pregnancy.

Insulin needs may also change during breastfeeding. Insulatard is generally considered compatible with breastfeeding because insulin is a naturally occurring hormone broken down in the infant's digestive tract, but a physician should monitor and may need to adjust the dose and diet in nursing mothers.

Hypoglycemia

Hypoglycemia is the most common and most serious risk with Insulatard. Risk increases with dose changes, skipped or delayed meals, unusual physical exertion, alcohol intake, and intercurrent illness. Patients and caregivers should be trained to recognize and treat early warning signs and should carry a fast-acting source of glucose at all times.

Do not interchange insulin products

Never switch between Insulatard and any other insulin product, brand, type, or concentration without a physician's explicit instruction and dose adjustment, as this can significantly change glucose control.

Individualized, physician-directed dosing

Never self-adjust the dose of Insulatard. Dose must be individualized and titrated by the treating physician based on regular blood glucose monitoring.

Injection site rotation

Rotate injection sites systematically to reduce the risk of lipodystrophy, which can affect insulin absorption.

Hypokalemia

Insulatard can lower serum potassium; use with caution in patients at risk of hypokalemia or taking other potassium-lowering medicines, with monitoring where appropriate.

Illness, exercise, and alcohol

Illness (especially with vomiting/reduced intake), unaccustomed exercise, and alcohol use can all change insulin requirements with Insulatard; patients should discuss a sick-day and exercise plan with their physician and monitor blood glucose more frequently in these situations.

Renal and hepatic impairment

Insulin requirements may be reduced in significant renal or hepatic impairment due to slower insulin clearance; closer monitoring is advised.

Overdose of Insulatard causes hypoglycemia, which may be mild (sweating, shakiness, hunger, palpitations, confusion) or severe (seizures, unconsciousness). Mild hypoglycemia can often be managed by taking a fast-acting source of sugar (such as glucose tablets or juice) followed by a longer-acting carbohydrate snack. For severe or worsening hypoglycemia, or if the person is unable to swallow safely or is unconscious, seek immediate emergency medical attention or contact emergency services/poison control; glucagon injection or intravenous glucose administered by trained personnel may be required. Do not attempt to manage severe hypoglycemia at home without professional guidance.

Store unopened vials/pens/cartridges of Insulatard in a refrigerator (2-8°C); do not freeze, and discard if it has been frozen. Once in use, the vial/pen currently being used may be kept at room temperature (below 30°C), away from direct heat and light, and should be discarded after the period stated on the product label (commonly around 4-6 weeks), even if some solution remains. Keep out of reach of children.

Pediatric use

Insulatard may be used in children with diabetes mellitus requiring insulin therapy under the supervision of a physician experienced in pediatric diabetes care; dosing is individualized and weight-based, with careful attention to hypoglycemia risk given children's variable eating and activity patterns.

Elderly

Older adults may be more susceptible to hypoglycemia and its consequences; a more conservative starting dose and more frequent glucose monitoring are recommended.

Renal impairment

Reduced insulin clearance may lower dose requirements; monitor glucose closely and adjust dose as needed.

Hepatic impairment

Reduced gluconeogenesis and insulin metabolism may lower dose requirements; monitor glucose closely.

Insulatard is generally used long-term/lifelong as part of ongoing diabetes management, since diabetes mellitus is a chronic condition. The dose and regimen are reviewed and adjusted periodically by the physician based on glycemic control (e.g., HbA1c and self-monitored glucose), and treatment should never be stopped or changed abruptly without medical advice.

Insulin Human [Long-Acting] belongs to the antidiabetic agent class, specifically long-acting (basal) human insulins.

Insulin Human [Long-Acting] acts by binding to insulin receptors on target cells (muscle, adipose tissue, and liver), triggering intracellular signaling that increases glucose uptake into muscle and fat, suppresses hepatic glucose output, and inhibits lipolysis and proteolysis while promoting glycogen, lipid, and protein synthesis. Its long-acting formulation delays absorption from the subcutaneous depot, producing a slow onset and prolonged, relatively flat basal insulin effect rather than a sharp mealtime peak.

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Insulatard can be used in pediatric patients with diabetes mellitus requiring basal insulin therapy, under specialist supervision, with individualized weight-based dosing and careful monitoring for hypoglycemia; safety and efficacy in very young children should be assessed by the treating pediatric endocrinologist. See Use in Special Populations for further detail.